Scemblix Dosage

Generic name: ASCIMINIB HYDROCHLORIDE 20mg
Dosage form: tablet, film coated
Drug class: BCR-ABL tyrosine kinase inhibitors

Medically reviewed by Drugs.com. Last updated on Nov 8, 2023.

2.1 Recommended Dosage in Patients with Ph+ CML-CP, Previously Treated with Two or More TKIs

The recommended dose of SCEMBLIX is 80 mg taken orally once daily at approximately the same time each day or 40 mg orally twice daily at approximately 12-hour intervals. The recommended dose of SCEMBLIX is taken orally without food. Avoid food consumption for at least 2 hours before and 1 hour after taking SCEMBLIX [see Clinical Pharmacology (12.2)].

Continue treatment with SCEMBLIX as long as clinical benefit is observed or until unacceptable toxicity occurs.

2.2 Recommended Dosage in Patients with Ph+ CML-CP with the T315I Mutation

The recommended dose of SCEMBLIX is 200 mg taken orally twice daily at approximately 12-hour intervals. The recommended dose of SCEMBLIX is taken orally without food. Avoid food consumption for at least 2 hours before and 1 hour after taking SCEMBLIX [see Clinical Pharmacology (12.2)].

2.3 Missed Dose

Once Daily Dosage Regimen: If a SCEMBLIX dose is missed by more than approximately 12 hours, skip the dose and take the next dose as scheduled.

Twice Daily Dosage Regimens: If a SCEMBLIX dose is missed by more than approximately 6 hours, skip the dose and take the next dose as scheduled.

2.4 Dosage Modifications

Dosage Modifications for Patients with Ph+ CML-CP, Previously Treated with Two or More TKIs

For the management of adverse reactions, reduce the SCEMBLIX dose as described in Table 1.

Dosage Modifications for Patients with Ph+ CML-CP with the T315I Mutation

For the management of adverse reactions, reduce the SCEMBLIX dose as described in Table 1.

Table 1: Recommended Dosage Reductions for SCEMBLIX for Adverse Reactions
Dosage Reduction	Dosage for Patients with CP-CML, Previously Treated with Two or More TKIs	Dosage for Patients with Ph+ CML-CP with the T315I Mutation
First	40 mg once daily OR 20 mg twice daily	160 mg twice daily
Subsequent Reduction	Permanently discontinue SCEMBLIX in patients unable to tolerate 40 mg once daily OR 20 mg twice daily.	Permanently discontinue SCEMBLIX in patients unable to tolerate 160 mg twice daily.

The recommended dosage modifications for the management of selected adverse reactions are shown in Table 2.

Table 2: SCEMBLIX Dosage Modification for the Management of Adverse Reactions
Abbreviations: ANC, absolute neutrophil count; PLT, platelets; ULN, upper limit of normal. 1Based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Adverse Reaction	Dosage Modification
Thrombocytopenia and/or neutropenia [see Warnings and Precautions (5.1)]
ANC less than 1.0 x 109/L and/or PLT less than 50 x 109/L	Withhold SCEMBLIX until resolved to ANC greater than or equal to 1 x 109/L and/or PLT greater than or equal to 50 x 109/L. If resolved: Within 2 weeks: resume SCEMBLIX at starting dose. After more than 2 weeks: resume SCEMBLIX at reduced dose. For recurrent severe thrombocytopenia and/or neutropenia, withhold SCEMBLIX until resolved to ANC greater than or equal to 1 x 109/L and PLT greater than or equal to 50 x 109/L, then resume at reduced dose.
Asymptomatic amylase and/or lipase elevation [see Warnings and Precautions (5.2)]
Elevation greater than 2.0 x ULN	Withhold SCEMBLIX until resolved to less than 1.5 x ULN. If resolved: Resume SCEMBLIX at reduced dose. If events reoccur at reduced dose, permanently discontinue SCEMBLIX. If not resolved: Permanently discontinue SCEMBLIX. Perform diagnostic tests to exclude pancreatitis.
Non-hematologic adverse reactions [see Warnings and Precautions (5.3, 5.4, 5.5)]
Grade 31 or higher	Withhold SCEMBLIX until recovery to Grade 1 or less. If resolved: Resume SCEMBLIX at reduced dose. If not resolved: Permanently discontinue SCEMBLIX.